WHO concludes PrePex male circumcision device meets international standards

The World Health Organization (WHO) announced on 31 May that it has “prequalified” the PrePex™ device for performing circumcision on adult men for HIV prevention, making it the first such device to be recognized as meeting international standards.
Prequalification does not replace countries’ own regulatory processes, however, and studies on the use of PrePex are under way or have been completed in nearly all the countries considered priorities for scale-up of voluntary medical male circumcision (VMMC) services.
One of these studies, conducted by the Male Circumcision Consortium (MCC) in collaboration with the National AIDS and STD Control Programme (NASCOP) and the Nyanza Reproductive Health Society (NRHS), is assessing the safety and acceptability of PrePex-assisted male circumcision among 425 men in routine health-care settings in Kenya, with results expected by September 2013.
Dr. Walter Obiero, NRHS director and a co-investigator on the study, says that this research will provide the information Kenya’s Ministry of Health needs to decide whether to add PrePex to the national VMMC programme.
“WHO prequalification is an important step in the process, but we also need to ensure that the PrePex device is a safe and acceptable complement to conventional male circumcision surgery in our local context,” he says.
Conducted at VMMC sites in Kisumu and Rachuonyo, the Kenya study will also examine a range of other service delivery issues, such as client satisfaction with the procedure, providers’ perceptions of ease of use, return for follow-up visits, time to wound healing, the training required to achieve proficiency in the PrePex procedure and the cost of the procedure.
WHO’s decision to prequalify PrePex was based on review of the regulatory dossier on the device, inspection of the quality management system for its manufacture, and clinical studies of its safety and effectiveness conducted in Rwanda, Uganda and Zimbabwe. WHO officials concluded that PrePex is safe for use among healthy men 18 years and older when used by trained mid-level providers in public health programmes, provided that surgical backup facilities and skills are available to manage within a few hours any events that could lead to serious complications, such as device displacements or early removals (including self-removals) during the week the device is worn. Careful monitoring and reporting of adverse events is necessary to better understand the frequency of such events.
The PrePex device consists of an elastic mechanism that fits closely around an inner ring, compressing the foreskin between the rings and cutting off its blood supply. The device must be worn for one week, so that the foreskin dries up and is then removed. The procedure involves minimal bleeding and can be performed without injected anaesthesia.
A note about PrePex prequalification on the WHO website states that some pain may occur during the first few hours to days after device placement and at removal, but men reported less pain with PrePex than with conventional surgery. In addition, the PrePex procedure takes less time to perform (including placement and removal) than conventional surgery, but the time to complete healing is one to two weeks longer with the PrePex device. In studies about 7 percent of men eligible for the conventional surgery were not eligible for PrePex-assisted circumcision.
Several other devices are under review, including the ShangRing, which has been studied in Kenya, Zambia and Uganda. Like PrePex, these devices, which do not require sutures (stitches), have the potential to make male circumcision easier and faster to perform and more acceptable to clients. Unlike PrePex, however, they require local injection of anaesthesia before the procedure.


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